Autoinjector apparatus

ABSTRACT

An autoinjector apparatus is disclosed which comprises a single-use cassette and an autoinjector. The cassette comprises a housing and a sleeve movably disposed in the housing. A syringe may be disposed in the sleeve and secured therein with a lock cap. The lock cap is affixed to a distal end of the sleeve and contacts the distal end of the syringe. A shield remover extends through an opening in a proximal end of the housing for removing a needle shield which covers a needle of the syringe. A cassette identification arrangement is provided on a surface of the housing to enable the autoinjector to identify the cassette. The autoinjector is provided with a detector for reading the cassette identification arrangement.

RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 14/112,479,filed Sep. 17, 2014, which is the U.S. national phase of InternationalPatent Application No. PCT/US2012/034535, filed Apr. 20, 2012, whichclaims the priority benefit of U.S. Provisional Application No.61/477,553, filed Apr. 20, 2011, the entire contents of each of whichare incorporated herein by reference.

FIELD

The present disclosure relates to an autoinjector apparatus. Moreparticularly, the present disclosure relates to an autoinjectorapparatus having a reusable autoinjector and a single-use cassetteuseable with the autoinjector, which conceals the injection needle of ahypodermic syringe before and after an injection.

BACKGROUND

Pre-filled hypodermic syringes provide several advantages for thehome-use market. These advantages include that pre-filled syringes maybe prepared for each medicament with exactly the required dosage.Further, they are easily operated, by merely advancing the stopper ofthe syringe. Aside from the costs of the particular medication used,pre-filled syringes are also economically manufactured. Consequently,all these advantages make pre-filled syringes commercially appealing.

Nevertheless, pre-filled syringes also have a significant drawback inthe marketplace. Specifically, many users are either frightened by anexposed needle or feel they are inherently incapable of performing aninjection. Because of aversions to exposed needles, as well as healthand safety issues that may be involved, various types of injectors andother devices have been developed for the specific purpose of concealingneedles from the user and automating the injection task to assist theuser in performing the injection.

In order to inject a fluid medicament into a patient when using ahypodermic syringe, generally three separate and distinct tasks must beperformed. These are: 1) insertion of the needle into the patient; 2)injection of the fluid medicament from the syringe into the patient; and3) withdrawal of the needle after the injection has been completed. Foreach task, the magnitude and direction of forces on the syringe, as wellas the location of their application, are different from the othertasks. For instance, compare the task of inserting the needle, with thetask of injecting the fluid medicament. Insertion of the needle requiresthat only minimal forces be applied on the syringe, and that they beapplied for only a very short period of time. On the other hand,injection of the medicament requires a much greater force be applied.Further, this force must be applied on the plunger of the syringe forwhat will typically be a relatively longer period of time. In comparisonwith both of these tasks, needle withdrawal requires the application ofa force in the opposite direction. These, and other similarconsiderations, become important when the injection process is to beautomated.

Springs for generating forces on a syringe in an automated process havebeen used heretofore for various purposes. A characteristic of springs,however, is that the magnitude and direction of a spring force are notvariable. Consequently, springs do not lend themselves to multi-taskingoperations. This limitation is particularly notable in a syringeinjection, which requires precise control of sequential forces ofdifferent magnitude (needle insertion and medicament injection). Thislimitation can be particularly problematic where it may be desirable touse the same device, at different times, to inject different medicationswith different fluid viscosities.

In addition to these mechanical considerations, the design of anautoinjector requires user-friendly considerations. In particular, it isdesirable that the injection needle of a syringe be operationallyconcealed from the view of a user. Preferably, this concealment ismaintained before, during and after an injection procedure. Further, itis desirable that operation of the syringe be limited to only thosetimes when the syringe is properly positioned for an injection.

Accordingly, an improved autoinjector apparatus is needed.

SUMMARY

The present disclosure relates to a single-use cassette for use with anautoinjector. The cassette comprises: a housing; an inner sleevedisposed in the housing and movable between first and second positions,wherein the inner sleeve is capable of having a syringe disposedtherein; and a lock cap for securing the syringe in the inner sleeve,the lock cap affixed to a distal end of the inner sleeve and capable ofcontact with the distal end of the syringe.

In one embodiment of the cassette, the lock cap comprises an elastomericbumper that is capable of contact with the distal end of the syringe.

In one embodiment of the cassette, the inner sleeve comprises at leastone receptacle at the distal end thereof and the lock cap comprises atleast one arm member inserted into the receptacle.

In one embodiment of the cassette, the at least one arm member of thelock cap comprises a barb arrangement for gripping an inner surface ofthe receptacle of the inner sleeve.

In one embodiment of the cassette, the cassette further comprises asyringe having a barrel and an injection needle disposed in the innersleeve.

In one embodiment of the cassette, the cassette further comprises ashield remover extending through an opening in a proximal end of thehousing for removing a needle shield from the syringe.

In one embodiment of the cassette, the shield remover comprises aspring-biased tab, the tab disposed within an aperture defined in a wallof the housing.

In one embodiment of the cassette, the shield remover comprises anelongated body having a proximal end and a distal end, the distal endcomprising at least one flexible tongue that expands outwardly when theshield remover is removed from the cassette to prevent the shieldremover from being reinserted into the cassette.

In one embodiment of the cassette, the cassette further comprises asyringe having a barrel and an injection needle.

In one embodiment of the cassette, the cassette further comprises atherapeutic product in the syringe.

In one embodiment of the cassette, the therapeutic product is selectedfrom the group consisting of Epogen®, Aranesp®, Enbrel® Neulasta®,Neupogen®, Nplate®, Vectibix®, Sensipar®, Xgeva® and Prolia®.

In one embodiment of the cassette, the therapeutic product is anantibody to IL-17 Receptor A.

In one embodiment of the cassette, the therapeutic product is anantagonist of angiopoietin-2 (e.g., AMG 36).

In one embodiment of the cassette, the therapeutic product is a TNFblocker or inhibitor.

In one embodiment of the cassette, the TNF blocker or inhibitor isetanercept.

In one embodiment of the cassette, the TNF blocker or inhibitor isadalimumab, certolizumab, golimumab or infliximab.

In one embodiment of the cassette, the cassette further comprises acassette identification arrangement on a surface of the housing toenable the autoinjector to identify the cassette.

In one embodiment of the cassette, the cassette identificationarrangement comprises at least one projection.

The present disclosure further relates to an apparatus for injection ofa therapeutic product. The apparatus comprises: an autoinjector; and asingle-use cassette for use with the injector, the cassette comprising:a housing; an inner sleeve disposed in the housing and movable betweenfirst and second positions; a syringe disposed in the inner sleeve; anda lock cap for securing the syringe in the inner sleeve, the lock capaffixed to a distal end of the inner sleeve and in contact with thedistal end of the syringe.

In one embodiment of the apparatus, the lock cap comprises anelastomeric bumper that contacts the distal end of the syringe.

In one embodiment of the apparatus, the inner sleeve comprises at leastone receptacle at the distal end thereof and the lock cap comprises atleast one arm member inserted into the receptacle.

In one embodiment of the apparatus, the at least one arm member of thelock cap comprises a barb arrangement for gripping an inner surface ofthe receptacle of the inner sleeve.

In one embodiment of the apparatus, the cassette further comprises ashield remover extending through an opening in a proximal end of thehousing for removing a needle shield from the syringe.

In one embodiment of the apparatus, the shield remover comprises aspring-biased tab, the tab disposed within an aperture defined in a wallof the housing to prevent removal of the shield remover from thecassette.

In one embodiment of the apparatus, the autoinjector comprises a pin forpushing the tab out of the aperture defined in the wall of the housingwhen the cassette is placed in the injector to thereby allow the shieldremover to be removed from the cassette.

In one embodiment of the apparatus, the shield remover comprises anelongated body having a proximal end and a distal end, the distal endcomprising at least one flexible tongue that expands outwardly when theshield remover is removed from the cassette to prevent the shieldremover from being reinserted into the cassette.

In one embodiment of the apparatus, the apparatus further comprises atherapeutic product in the syringe.

In one embodiment of the apparatus, the therapeutic product is selectedfrom the group consisting of Epogen®, Aranesp®, Enbrel® Neulasta®,Neupogen®, Nplate®, Vectibix®, Sensipar®, Xgeva®, and Prolia®.

In one embodiment of the apparatus, the therapeutic product is anantibody to IL-17 Receptor A.

In one embodiment of the apparatus, the therapeutic product is anantagonist to angiopoietin-2 (e.g., AMG 386).

In one embodiment of the apparatus, the therapeutic product is a TNFblocker or inhibitor.

In one embodiment of the apparatus, the TNF blocker or inhibitor isetanercept.

In one embodiment of the apparatus, the TNF blocker or inhibitor isadalimumab, certolizumab, golimumab or infliximab.

In one embodiment of the apparatus, the cassette further comprising acassette identification arrangement on a surface of the housing toenable the autoinjector to identify the cassette.

In one embodiment of the apparatus, the cassette identificationarrangement comprises at least one projection.

In one embodiment of the apparatus, the autoinjector comprises adetector for reading the cassette identification arrangement to identifythe cassette.

The present disclosure further relates to an apparatus for injection ofa therapeutic product. The apparatus comprises: an autoinjector; and asingle-use cassette for use with the injector, the cassette comprising:a housing; a sleeve disposed in the housing and movable between firstand second positions; a syringe disposed in the sleeve; and a shieldremover extending through an opening in a proximal end of the housingfor removing a needle shield from the syringe.

The present disclosure further relates to a single-use cassette for usewith an autoinjector. The cassette comprises: a housing; a sleevedisposed in the housing and movable between first and second positions,wherein the sleeve is capable of having a syringe disposed therein; anda shield remover extending through an opening in a proximal end of thehousing for removing a needle shield from the syringe.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying figures show a preferred embodiment according to thepresent disclosure and are exemplary rather than limiting.

FIG. 1 is an elevational side view of an exemplary embodiment of anautoinjector apparatus 100 comprising an autoinjector 300 and a cassette200.

FIG. 2A is an exploded perspective view of an exemplary embodiment ofthe cassette 200 comprising an outer housing 210; an inner sleeve 220; asyringe 260; a lock cap 230; a cover 250 and a shield remover 240.

FIG. 2B is a top down front perspective view of the cassette 200illustrating a side wall 211 of the outer housing 210; a window 212 ofthe outer housing 210; a pin 215 of the outer housing 210; and theshield remover 240.

FIG. 2C is a sectional side view of the cassette 200 illustrating thesyringe 260 which may comprise a barrel 261, a fluid chamber 262, apredetermined dose of a pharmaceutical product 267, an injection needle265, an outwardly extending flange 263, a non-rigid protective needleshield 266, and a moveable plunger-stopper 264; and illustrating theshield remover 240 which may comprise a cantilever spring member 247 anda projection or tab 248.

FIG. 3A is a bottom up, front perspective view of the cassette 200illustrating the cassette outer housing 210 which may comprise a bottomsurface 210B with projections 210P.

FIG. 3B is a bottom view of the cassette of FIG. 3A illustrating thecassette outer housing 210; the projections 210P; the bottom surface210B; a latch mechanism 218 which may comprise a pair of parallelextending, resilient locking arms 218 a, 218 b, and locking detent slots219 a and 219 b; and an inner sleeve pin 268.

FIG. 4A is a rear perspective view of an exemplary embodiment of theshield remover 240 illustrating the cantilever spring member 247 and theprojection or tab 248, wherein the shield remover 240 may comprise ahollow body 241; a closed end 242; an open end 243; a generallycylindrical portion 241T of the body 241; a generally rectangular keyportion 241K of the body 241; an expandable partial collar structure 245having a plurality of flexible, outwardly flared tongues 245T; anoutwardly extending flange or gripping member 244 having parallel sides244S and opposing ends 244E; a bottom wall 241W of the key portion 241K;and an inclined locking surface 248S of the projection or tab 248.

FIG. 4B is a sectional front perspective view of another exemplaryembodiment of the shield remover 240 illustrating the gripping member244; the closed end 242 of the body 241; the cantilever spring member247; the projection or tab 248; the inclined locking surface 248S of theprojection or tab 248; and the key portion 241K of the body 241, whereinthe shield remover 240 may comprise a metal tubular insert 246 havingneedle shield gripping teeth 246T; and an interior surface 2411 of thecylindrical body portion 241T.

FIG. 4C is a sectional side view of another exemplary embodiment of theshield remover 240 illustrating the gripping member 244; the closed end242 of the body 241; the cantilever spring member 247; the projection ortab 248; the inclined locking surface 248S of the projection or tab 248;the key portion 241K of the body 241; and the interior surface 2411 ofthe cylindrical body portion 241T, wherein the shield remover 240alternatively comprises needle shield gripping teeth 246T′.

FIG. 4D is a bottom up rear perspective view of a portion of thecassette 200 of FIG. 2B illustrating the shield remover 240; thecassette outer housing 210; the projections 210P; the outer housingbottom surface 210B; the outer housing aperture 210A; and the shieldremover projection or tab 248.

FIG. 4E is a bottom up front perspective view of a portion of thecassette 200 with the shield remover 240 removed from the cassette 200,illustrating the expandable partial collar structure 245 of the shieldremover 240; aperture 214A of the cassette outer housing 210, the outerhousing bottom wall 210B; and aperture 210A of the outer housing 210.

FIG. 4F is a sectional side view of a portion of the cassette 200illustrating the inner sleeve 220; the outer housing 210; the outerhousing end wall 214; the outer housing aperture 214A; the shieldremover 240; the injection needle 265; the needle shield 266; thecantilever spring member 247; the projection or tab 248; the outerhousing aperture 210A.

FIG. 4G is a sectional side view of the cassette 200 installed in theautoinjector 300 illustrating the shield remover 240; the tab 248 of theshield remover 240; the needle shield 265; the outer cassette housing210; the outer housing bottom wall 210B; the aperture 210A of the outercassette housing 210; a chassis 301 of the autoinjector 300 and a pin Pprovided by the chassis 301.

FIG. 4H is a sectional side view of the cassette 200 installed in theautoinjector 300 illustrating the shield remover 240; the needle shield265; the outer cassette housing 210; the outer housing bottom wall 210B;and the aperture 210A of the outer cassette housing 210; the projections210P; the detector 370; the chassis 301 of the autoinjector; and the pinP.

FIG. 5A is a front perspective view of an exemplary embodiment of thelock cap 230 which may comprise an annular body 231; an outer surface2310; an inner surface 2311, opposing arms 232; cut-out members 233; abarbed ends 234; a soft elastomeric ring-shape bumper 235; and anopening 236.

FIG. 5B is a rear perspective view of a portion of an inner sleeve 220of the cassette 200 illustrating the syringe 260; the inner sleeve 220;the lock cap 230; the lock cap annular body 231; the lock cap outersurface 2310; the lock cap opposing arms 232; the lock cap cut-outmembers 233; the lock cap soft elastomeric ring-shape bumper 235; thelock cap opening 236; the flange 263 of the prefilled syringe 260 andopposing receiving receptacles 220R of the inner sleeve 220.

FIG. 5C is a side view of a portion of the inner sleeve with 220 thesyringe 260 inserted therein and locked in place with the lock cap 230,and illustrating the lock cap annular body 231; the lock cap outersurface 2310; the lock cap opposing arms 232; the lock cap cut-outmembers 233; the lock cap soft elastomeric ring-shape bumper 235; theflange 263 of the prefilled syringe 260 and opposing receivingreceptacles 220R of the inner sleeve 220.

FIG. 5D is a front perspective view of a portion of the inner sleeve 220and another embodiment of the lock cap numbered 230′ comprising anannular body 231; opposing arms 232; and a barb arrangement 234′.

FIG. 6A is a front elevational view of an exemplary embodiment of theautoinjector 300 which may comprise a casing 302, a handle section 304,a handle 305, a cassette receiving section 306, a cassette door 308, auser interface 312, a speaker aperture 314, a speed selector switch 316,and an end wall 318.

FIG. 6B is an elevational view of a first side of the autoinjector 300of FIG. 6A illustrating the casing 302, the handle section 304, thehandle 305, a soft grip area 305S, the cassette receiving section 306,the cassette door 308, a window 310A, the user interface 312, asettings/mute switch 315, the speed selector switch 316, and the endwall 318.

FIG. 6C is a rear elevational view of the autoinjector 300 of FIG. 6Aillustrating the casing 302, the handle section 304, the handle 305, thesoft grip area 305S, the cassette receiving section 306, windows 310Aand 310B, and the end wall 318.

FIG. 6D is an elevational view of a second side of the autoinjector 300of FIG. 6A illustrating the casing 302, the handle section 304, thehandle 305, the soft grip area 305S, the cassette receiving section 306,the cassette door 308, a window 310B, the user interface 312, an ejectbutton 317, the speed selector switch 316, and the end wall 318.

FIG. 6E is an elevational view of a first end of the autoinjector 300 ofFIG. 6A illustrating the end wall 318, a target light 320, a cassettedoor aperture 308A, a skin sensor 380.

FIG. 6F is an elevational view of a second end of the autoinjector 300of FIG. 6A illustrating a start button 307.

FIG. 7 is a state diagram illustrating the decision logic forcontrolling skin sensor 380 with the microprocessor 350 of theautoinjector 300, according to an embodiment of the present disclosure.

FIG. 8 is a sectional side view of the autoinjector apparatus 100illustrating the autoinjector 300 and the cassette 200, wherein theautoinjector 300 may comprise the chassis 301, a casing 302, a motorizedinsertion drive 330, a motorized extrusion drive 340, a microprocessor350, a battery 360; and wherein the cassette comprises the syringe 260.

FIG. 9A is a flow chart illustrating the decision logic for controllingthe various functions of the autoinjector with the microprocessor,according to an exemplary embodiment of the present disclosure.

FIG. 9B is a flow chart illustrating the decision logic for controllingthe various functions of the autoinjector with the microprocessor,according to an exemplary embodiment of the present disclosure.

FIG. 10A is a top down perspective side view of an exemplary embodimentof the motorized insertion drive 330 which may comprise an insertiondrive motor 331, a drive link or rack 332, an insertion drive gear train333 including a plurality of gears 3331, 3332, 3333, 3334, a top racksurface 332T, a bottom rack surface 332B, spaced-apart first and secondprotrusions, 3321 and 3322, and rack teeth 334.

FIG. 10B is a bottom up perspective view, of an exemplary embodiment ofthe motorized insertion drive 330 which may comprise an insertion drivemotor 331, a drive link or rack 332, an insertion drive gear train 333including a plurality of gears 3331, 3332, 3333, 3334, a top racksurface 332T, a bottom rack surface 332B, spaced-apart first and secondprotrusions, 3321 and 3322, and rack teeth 334.

FIG. 11A is an exploded perspective side view of a plunger rod 342, alead screw 343, and a nut 345 of an exemplary embodiment of themotorized extrusion drive illustrating a pusher 342P of the plunger rod342, an end face 342EF of the plunger rod 342, an internal screw thread345T of the nut 345, an external screw thread 343T of the lead screw343, and a holder 345H of the nut 345.

FIG. 11B is an assembled perspective side view of the plunger rod 342,the lead screw 343, and the nut 345 of FIG. 11B, illustrating the pusher342P of the plunger rod 342, the end face 342EF of the plunger rod 342,the internal screw thread 345T of the nut 345, the external screw thread343T of the lead screw 343, and the holder 345H of the nut 345.

FIG. 11C is a perspective view of a portion of the motorized extrusiondrive 340, illustrating an extrusion drive motor 341, the plunger rod342, the lead screw 343, an extrusion drive gear train 344, the pusher342P, the nut 345, the external screw thread 343T of the lead screw 343,the holder 345H of the nut 345, and a plurality of gears 3441, 3442,3443, 3444, 3445, 3446 of the extrusion drive gear train.

FIG. 12 is a front elevational view of an exemplary embodiment of theautoinjector 300 which illustrates progress LEDs 550 of the userinterface 312.

FIG. 13 is a front elevational view of an exemplary embodiment of theautoinjector 300 which illustrates various exemplary icons displayed bythe user interface 312.

DETAILED DESCRIPTION

FIG. 1 illustrates an elevational view of an exemplary embodiment of anautoinjector apparatus 100 according to the present disclosure. Theautoinjector apparatus 100 comprises an autoinjector 300 and a cassette200. The autoinjector 300 may comprise a cassette door 308, which in anopen position, (as shown) allows insertion therein of the cassette 200,and which in a closed position (e.g., FIG. 6B), aligns the cassette 200with insertion and extrusion drives 330 and 340, respectively (FIG. 8)of the autoinjector 300. The autoinjector 300 may be constructed andadapted for hand-held operation and be reusable. The cassette 200 may beconstructed and adapted to house and protect a syringe 260 (e.g., FIG.2A), which may be prefilled with a predetermined dose of apharmaceutical product. The cassette 200 facilitates and enables easyuse of the syringe with the autoinjector 300 and helps prevent needlesticks before and after use. Moreover, the cassette 200 may beconstructed and adapted for single, disposable use.

FIG. 2A illustrates an exploded perspective view of an exemplaryembodiment of the cassette 200, according to the present disclosure. Thecassette 200 may comprise an outer housing 210, an inner sleeve 220slidably moveable within the outer housing 210, a syringe 260 disposedwithin or held by the inner sleeve 220, and a shield remover 240 forremoving a protective needle shield 266 of the syringe 260. The outerhousing 210 may comprise a proximal end wall 214 and an open distal end216. The proximal end wall 214 of the outer housing 210 may include anaperture 214A having a size and shape for receiving therethrough theshield remover 240. The inner sleeve 220 may comprise a proximal endwall 222 and an open distal end 224. The proximal end wall 222 of theinner sleeve 220 may include an aperture 222A having a size and shapefor receiving therethrough the protective needle shield 266 of thesyringe 260. The cassette 200 may further comprise a lock cap 230 forclosing the open distal end 224 of the inner sleeve 220 and locking thesyringe 260 within the inner sleeve 220. The cassette 200 may furthercomprise a cover 250 for closing the open distal end 216 of the outerhousing 210. The cover 250 provides for tamper resistance by encasingthe inner sleeve 220 and the syringe 260 containing a pharmaceuticalproduct 267, within the outer housing 210 of the cassette 200, and alsocompletes the cosmetic appearance of the cassette 200.

FIG. 2B illustrates a top down front perspective view of the cassette200. The outer housing 210 of the cassette 200 may comprise an elongatedopening or window 212 in each side wall 211 thereof. The windows 212 maybe disposed opposite to and aligned with one another. Further, the innersleeve 220 of the cassette 200 may be made from a transparent, rigidmaterial, such as a clear polycarbonate. The windows 212 in the sidewalls 211 of the outer housing 210 in combination with the transparentinner sleeve 220, allow viewing of the syringe 260 housed within theinner sleeve 220 (FIG. 2C). The wall portions of the inner sleeve 220viewable through the windows 212 of the outer housing 210 may comprisefill volume indicia (not shown). The outer housing 210 of the cassette200 may also include a pin 215 or any other suitable mechanicalstructure that prevents the cassette 200 from being inserted into thecassette door 308 in the wrong direction and/or orientation. An “arrow”icon may be provided on the shield remover 240 or the outer housing 210(not shown) to indicate the proper direction and orientation of cassetteinsertion into the cassette door 308.

FIG. 2C illustrates a sectional side view of the cassette 200. As can beseen, the inner sleeve 220 may comprise an inner sleeve pin 268, whichmay be engaged by an insertion drive 330 of the autoinjector 300 (FIG.8) during the operation thereof. When driven by the insertion drive 330,the pin 268 moves the inner sleeve 220 within the outer housing 210 ofthe cassette 200. The inner sleeve 220 may be sized and shaped toreceive the syringe 260 therein.

Referring still to FIG. 2C, the syringe 260 may comprise a barrel 261that defines a fluid chamber 262. The fluid chamber 262 may be prefilledwith a predetermined dose of a pharmaceutical product 267. Thepharmaceutical product 267 may have a viscosity that depends on thetemperature of the product 267. The syringe 260 may further comprise aninjection needle 265 removably or fixedly disposed at a proximal end ofthe barrel 261, and an outwardly extending flange 263 disposed at adistal end of the barrel 261. The injection needle 265 may communicatewith the fluid chamber 262 to allow dispensing of the predetermined doseof a pharmaceutical product 267 expelled from the fluid chamber 262 ofthe syringe barrel 261. The syringe 260 may further comprise a moveableplunger-stopper 264, disposed within the fluid chamber 262 of the barrel260, for expelling the predetermined dose of the pharmaceutical product267 from the chamber 261 so that it may be dispensed through theinjection needle 265. The protective needle shield 266 mentionedearlier, covers the injection needle 265 and may be made of a non-rigidmaterial. In one exemplary embodiment, the syringe 260 may comprise astandard 1-mL long glass syringe. The lock cap 230 closes the distal end224 of the inner sleeve 220 and fixedly secures a proximal end 261P ofthe syringe barrel 261 against an inner edge surface formed at thejunction of the interior surface of the proximal end wall 222 and theaperture 222A of the inner sleeve 220, so that the syringe 260 moveswith the inner sleeve 220 as it travels within the outer housing 210,during the operation of the autoinjector 300.

Referring to FIGS. 3A and 3B, the outer housing 210 of the cassette 200may comprise a cassette identification arrangement which providesinformation that identifies the cassette 200, e.g., information aboutthe contents of the syringe 260 contained within the cassette 200 and/orother cassette/syringe characteristics. In one exemplary embodiment, thecassette identification arrangement may comprise one or more bumps orprojections 210P provided on a bottom surface 210B of the outer housing210 of the cassette 200. As illustrated in FIGS. 4G and 4H, theprojection(s) 210P may be sensed by or engage a detector 370 in theautoinjector 300 when the cassette 200 is inserted into the door 308 ofthe autoinjector 300 and the door 308 is closed. The detector 370 may beelectrically coupled to a microprocessor (e.g. microprocessor 350illustrated in FIG. 8) contained within the autoinjector 300, whichenables the autoinjector 300 to read the cassette identificationarrangement to thereby identify the cassette 200. In one exemplaryembodiment, a predetermined number of projections 210P may be located onthe bottom surface 210B of the outer housing 210 in predeterminedlocations, and the detector 370 may comprise a key pad of plural keys(not shown). Certain ones of the plural keys may be actuated by thecassette projections 210P when the cassette 200 is installed in theautoinjector 300, depending upon the location and number of theprojections 210P. Each key actuated by one of the projections 210P mayprovide information that allows the autoinjector 300 to identify thecassette 200. In some embodiments, the cassette identificationarrangement identifies the drug delivery profile of the pharmaceuticalproduct provided in the cassette 200. Therefore, upon insertion andrecognition of a valid cassette and the information provided by cassetteidentification arrangement, available preset drug extrusion speed rangescommensurate with the drug delivery profile of the pharmaceuticalproduct provided in the cassette 200 may be automatically registered bythe autoinjector 300. Available speed ranges are dependent upon thesyringe fill volume and pharmaceutical product characteristics, such asviscosity. For example, but not limitation, if the cassetteidentification arrangement comprises plural projections 210P, oneprojection may indicate a 1 mL fill and two projections may indicate a0.5 mL fill and additional projections may be provided to identify thepharmaceutical product and/or characteristics.

FIG. 3B also illustrates a latch mechanism 218 that may be provided onthe bottom wall 210B of the outer housing 210 of the cassette 200. Thelatch mechanism 218 may include a pair of parallel extending, resilientlocking arms 218 a, 218 b. The locking arms 218 a and 218 b may eachdefine a locking detent slot 219 a and 219 b, respectively. The pin 268of the inner sleeve 220 may engage the detent slots 219 a, 219 b of thelatch mechanism 218 when the syringe 260 is in a home position with theinjection needle 265 of the syringe 260 concealed in the cassette 260 ina needle concealed position, thereby locking of latching the innersleeve 220 into place within the outer housing 210 of the cassette 200.During an injection cycle, the insertion drive 330 of the autoinjector300 (FIG. 8) may spread the resilient locking arms 218 a, 218 b apart tounlatch or release the inner sleeve pin 268 from the detent slots 219 a,219 b of the latch mechanism 218, thereby allowing the unlatched innersleeve 220 containing the syringe 260 to be freely moved by theinsertion drive 330, which pushes on the inner sleeve pin 268 to movethe inner sleeve 220 relative to the outer housing 210 from the homeposition, where the injection needle 265 is in the needle concealedposition, to an injection position, where the injection needle 265 is ina needle extended position that allows it to penetrate the skin at theinjection site. At the end of the injection, cycle, the insertion drive330 pulls the inner sleeve pin 268 back into the detent slots 219 a, 219b, thereby returning the inner sleeve 220 (which contains the syringe260) to the home position, where the injection needle 265 is in theneedle concealed position.

Cassettes of similar structure and operation are described in greaterdetail in the following patent applications, each of which isincorporated herein by reference in its entirety: US Publ. Nos.2009/0292246 and 20100022955; and PCT Publ. No. WO 2009/143255.

The shield remover 240, illustrated in detail in FIGS. 4A-4F, grips theprotective needle shield 266 covering the injection needle 265 of thesyringe 260 (FIG. 2C) thereby allowing the shield remover 240 to be usedfor removing the needle shield 266. Further, the shield remover 240engages the cassette 200 in a locking manner so that it can not beeasily withdrawn from the cassette 200 unless the cassette 200 isproperly installed in the autoinjector 300. This feature prevents theneedle shield 266 from being inadvertently removed from the syringe 260when, for example, the cassette is handled by the user. In addition, thepresence of the shield remover 240 provides an indication that thecassette 200 has not been previously used or tampered with.

As illustrated in FIG. 4A, the shield remover 240 in one exemplaryembodiment may comprise a hollow body 241 having a closed end 242 and anopen end 243. The hollow body 241 may comprise a generally cylindricalportion 241T and a generally rectangular, key-like portion 241Kextending outwardly from one side of the cylindrical portion 241T. Theopen end 243 of the cylindrical body portion 241T may define anexpandable partial collar structure 245 formed, for example, by aplurality of flexible, outwardly flared tongues 245T. The cylindricalportion 241T of the body 241 may taper down toward the closed end 242thereof. An outwardly extending flange that functions as a grippingmember 244 may be defined at the closed end 242 of the cylindrical bodyportion 241T. The gripping member 244 may comprise flat, parallel sides244S connecting rounded opposing ends 244E. The gripping member 244allows users with manual dexterity issues to easily remove the needleshield 266 from the syringe 260, after the cassette 200 is properlyinstalled in the autoinjector 300.

As illustrated in FIG. 4B, the shield remover 240 in some embodimentsmay comprise a metal tubular insert 246 frictionally engaged with aninterior surface 2411 of the cylindrical body portion 241T of the body241. The metal insert 246 may have a slit along its length (not visible)and may comprise two or more spaced-apart needle shield gripping teeth246T projecting inwardly into the interior of the cylindrical bodyportion 241T and generally toward the closed end 242 thereof. In anotherexemplary embodiment, as shown in FIG. 4C, needle shield gripping teeth246T′ may be formed on the interior surface 2411 of the cylindrical bodyportion 241T.

As illustrated in FIGS. 4A-4C, the key-like body portion 241K of theshield remover 240 prevents rotation of the shield remover 240 withinthe proximal end wall 214 of the outer housing 210 of the cassette 200.The key-like body portion 241K may comprise a bottom wall 241W thatincludes a locking structure formed by a cantilever spring member 247and a downwardly extending projection or lock tab 248 provided at thefree end of the spring member 247. The lock tab 248 may comprise anundercut formed by an inclined surface 248S that faces the closed end242 of the cylindrical body portion 241T and defines an acute angle 0with the outer surface 2470 of the cantilever member 247.

FIG. 4F illustrates a sectional side view of a proximal portion of thecassette 200. As illustrated, the needle cover 266 of the syringe 260may be disposed within the cylindrical body portion 241T (FIG. 4A) ofthe shield remover 240 such that the needle gripping teeth 246T (orteeth 246T′ illustrate in FIG. 4C) of the shield remover 240 grip theouter surface of the needle cover 266. The body 241 of the shieldremover 240 may extend through the aperture 214A formed in the proximalend wall 214 of the outer housing 210 of the cassette 200, which locatesthe gripping member 244 of the shield remover 240 outside of thecassette 200. The locking structure of the shield remover 240, formed bythe cantilever spring member 247 and lock tab, may be disposed withinthe marginal proximal portion of the outer cassette housing 210, suchthat it locks the shield remover 240 in place in the cassette 200, in atamper-resistant manner. Locking may be facilitated by the cantileverspring member 247, which forces or biases the tab 248 into a lockaperture 210A (best illustrated in FIGS. 4D and 4E) that may be definedin the bottom surface 210B of the outer housing 210 of the cassette 200.The lock tab 248 engaged with the lock aperture 210A of the cassetteouter housing 210, substantially prevents withdrawal of the shieldremover 240 from the cassette 200, unless the cassette 200 is properlyinstalled within the autoinjector 300. Because the shield remover 240 isattached to the needle shield 266 and locked within the cassette 200,the needle shield 266 may not be inadvertently removed from the syringe260, prior to proper installation in the autoinjector 300. The presenceof the shield remover 240 also provides an indication that the cassette200 has not been previously used or tampered with.

FIG. 4G is a sectional side view illustrating the cassette 200 installedin the access door of the autoinjector (both not visible) prior toclosing of the door, and FIG. 4H illustrates a sectional side view ofthe cassette 200 after the access door of the autoinjector (both notvisible) has been closed. As illustrated in FIGS. 4G and 4H, theautoinjector 300 may include a chassis 301 (also see FIG. 8) for holdingthe cassette 200 within the autoinjector 300. The chassis 301 mayinclude a pin P, and the cassette identification detector 370 describedearlier. As illustrated in FIG. H, closure of the access door positionsthe cassette 200 in or on the chassis 301 of the autoinjector 300 sothat the cassette identification projections 210P can be read by thedetector 370, thereby allowing automatic identification of the cassette200. In addition, the pin P presses the locking structure tab 248 of theshield remover 240 up, thereby overcoming the biasing force provided bythe cantilever spring member 247. As the lock tab 248 moves up, itreleases from the tab receiving aperture 210A in the bottom wall 210B ofthe outer cassette housing 210 (FIG. 4F), thereby unlocking the shieldremover 240 from the outer housing 210 of the cassette 200. With thelocking structure of the shield remover 240 unlocked, a user can nowgrasp the gripping member 244 of the shield remover 240 and withdraw itfrom the cassette 200 and the autoinjector 300, thereby removing theneedle shield 266 and uncovering the injection needle 265.

FIG. 4E illustrates a bottom up, front perspective view of the proximalportion of the cassette 200 with the shield remover 240 removed from thecassette 200. As can be seen, once the shield remover 240 is removed,the tongues 245T of the expandable partial collar structure 245 expandor spread outwardly to prevent the shield remover 240 and the needleshield 266 attached thereto (not visible) from being re-inserted intothe aperture 214A formed in the proximal end wall 214 of the cassetteouter housing 210. The absence of the shield remover 240, therefore,provides an indication to the user that the cassette 200 has alreadybeen used or has been tampered with.

The lock cap 230, illustrated in FIGS. 5A-5C, locks the syringe 260 inthe inner sleeve 220 with a predetermined force which may be set duringassembly of the cassette 200. The lock cap 230 may comprise a generallyflat, annular body 231 having outer and inner surfaces 2310 and 2311,and opposing arms 232 depending from the body 231, away from the innersurface 2311 thereof. Each of the arms 232 may comprise a cut-out member233 with a barbed end 234. In some embodiments, the cut-out members 233may be spring-like. The members 233 may extend outwardly from the arms232 and toward the body 231. The body 231 can be made from a metal orrigid plastic material. A soft elastomeric ring-shape bumper 235 may beaffixed to the inner surface 2311 of the body 231. The body 231 andbumper 235 may define an opening 236 which can be dimensioned to allow aplunger rod 343 actuated by a motorized extrusion drive 340 of theautoinjector 300 (FIG. 11C), to pass through the lock cap 230 and engageand move the plunger-stopper 264 through the fluid chamber 262 of thesyringe barrel 261 during the operation of the autoinjector 300. Thelock cap 230 may be dimensioned to receive the flange 263 of the syringe260 between the opposing arms 232 thereof, in a slip-fit manner with thebumper 235 engaging a top surface 263T of the flange 263 as illustratedin FIGS. 5B and 5C. The arms 232 of the lock cap 230 may be insertedinto opposing receiving receptacles 220R formed at a distal end of theinner sleeve 220 when the syringe 260 is assembled into the inner sleeve220. The barbs 234 of the arms 232 grip the inner surfaces of thereceiving receptacles 220R to lock the lock cap 230 into position,thereby lockingly holding the syringe 260 in the inner sleeve 220. Thearms 232 of the lock cap 230 may be inserted into the receptacles 220Rof the inner sleeve 220 a selected distance to limit the amount of force(to a predetermined value) applied to the syringe 260 during assemblyinto the cassette 200 and during usage.

FIG. 5D illustrates an alternate embodiment of the lock cap numbered230′. The lock cap 230′ is similar to the lock cap 230 of FIGS. 5A-5C,but omits the cut-out members 233 and instead, provides a barbarrangement 234′ at the end of each arm 262.

Referring again to FIGS. 2A-2C, the cover 250 attaches to a distal endof the outer housing 210 of the cassette 200 to close a distal end ofthe cassette 200. The cover 250 may be a generally planar member havinga shape which matches that of the distal end 216 of the outer housing210. The cover 250 may comprise two or more locking arms 253 that extendfrom an inner surface 251 of the cover 250 and lockingly engagecorresponding receptacles 255 extending through the side walls 211 ofthe outer housing 210. In addition, any detent structure or othersuitable locking arrangement (not shown) formed in, on, or through theouter housing 210, adjacent to the distal end 216 thereof may be usedfor attaching the cover 250. The cover 250 may further comprise anopening 254 which axially aligns with the opening 236 defined by thelock cap 230. The opening 254 in the cover 250, like the opening 236 ofthe lock cap 230, may be dimensioned to allow the plunger rod 342actuated by the motorized extrusion drive 340 of the autoinjector 300(FIG. 8), to pass through the cover 250 and engage and move theplunger-stopper 264 through the fluid chamber 262 of the syringe barrel261 during the operation of the autoinjector 300.

Referring now to FIGS. 6A-6F, the autoinjector 300 may comprise a casing302 having a handle section 304 and a cassette receiving section 306inline with the handle section 304. To aid patients with manualdexterity issues, the handle section 304 of the autoinjector casing 302may define an ergonomically shaped handle 305 with a soft grip area305S. The cassette receiving section 306 comprises the cassette door 308(FIGS. 6B and 6D) described earlier. The cassette door receives thecassette 200 in an open position (FIG. 1) and aligns the cassette 200with insertion and extrusion drives, and other structures and componentsof the autoinjector 300 in a closed position. The cassette door 308 mayinclude a “cassette” icon that indicates the insertion entry point forthe cassette 200. The cassette receiving section 306 of the casing 302may comprise windows 310A, 310B on opposing sides thereof that alignwith the windows 212 (FIG. 2B) of the cassette 200 when the cassettedoor 308 is closed with the cassette 200 correctly installed therein. Inone or more embodiments, the windows 310A, 310B may be double-layered.One or more lights (not shown) may be provided inside the casing 302 toevenly backlight illuminate the cassette windows 212 and the syringe 260disposed within the inner sleeve 220 of the cassette 200, so that theuser can observe the injection cycle through the windows 310A, 310B ofthe autoinjector 300, i.e., observe the initial and end positions of theplunger-stopper 264 of the syringe 260 during the syringe content(hereinafter “drug”) extrusion process, as well as syringe movementswithin the cassette 200.

Referring still to FIGS. 6A, 6B, 6D, and 6F, the autoinjector 300 mayfurther comprise a user interface 312 and an audio speaker (not shown).The user interface 312 (best illustrated in FIG. 6A) may be located inthe cassette receiving section 306 of the casing 302, and providesvarious visual indicators. The audio speaker may be disposed inside thecasing 302 and provides various audible indicators. The audio speakermay audibly communicate with the external environment via a speakeraperture 314 formed in the casing 302 in the cassette receiving section306. The visual and audible indicators generated by the user interface312 and the audio speaker can tell the user when the autoinjector 300 isready for use, the progress of the injection process, injectioncompletion, the occurrence of any errors, and other information. Theautoinjector 300 may further comprise one or more of a settings/muteswitch 315, a speed selector switch 316, a start button 307, and aneject button 317. The settings/mute switch 315 (FIG. 6B) may be locatedin the cassette receiving section 306 of the casing 302. The mute switch315 may be constructed and adapted allow the user to turn on and off allsynthesized sounds, except error sounds, and to respond in real-time sothat if the user begins the injection process and changes the muteswitch to off, the sounds are immediately muted. The mute switch 315 mayalso be constructed and adapted to slide toward a “mute” icon to mutethe audio speaker. A light indicator may be provided to confirm the“mute” state. The speed selector switch 316 (FIGS. 6A and 6B) may belocated in the cassette receiving section 306 of the casing 302. Thespeed selector switch 316 may be constructed and adapted to allow theuser to select among a plurality of preset drug delivery (extrusion)speeds to accommodate personal patient preference. The speed selectorswitch 316 may comprise a three switch positions. Other embodiments ofthe speed selector switch may comprise two switch positions, or 4 ormore switch positions. In still other embodiments, the speed selectorswitch may be of the infinitely variable type. In some embodiments,changing the position of the switch 316 prior to injection changes thespeed of drug extrusion during injection while changing the position ofthe speed selector switch 316 during injection, does not change thespeed of the injection in real time. The autoinjector 300 may also beprovided with one or more demo cassettes to allow the user to experimentwith different speeds of drug delivery. The start button 307 at a freeend of the handle 305. The button 307 may include an indentation 307Tfor optimizing thumb placement on the button 307. The button 307 may bemade of a translucent material that allows a lighting effect toilluminate the button as signals. The eject button 317 (FIG. 6D) may belocated in the cassette receiving section 306 of the casing 302. Theeject button 317 may include an indentation 3171 for optimizing fingerplacement on the button 317. In some embodiments, the eject button 317may be controlled by the microprocessor (e.g. microprocessor 350illustrated in FIG. 8) of the autoinjector 300, which may be programmedto eliminate accidental inputs during the injection process.

Referring again to FIG. 6E, the cassette receiving section 306 of thecasing 302 and the cassette door 308 may form a proximal end wall 318 ofthe autoinjector 300. The proximal end wall 318 may be configured as abroad, flat and stable base for easily positioning the autoinjector 300on a support surface, after removal of the shield remover 240 or whenthe autoinjector 300 does not contain the cassette 240. The portion ofthe proximal end wall 318 formed by the cassette door 308 may include anaperture 308A that is sized and shaped to allow the shield remover 240to be removed from the cassette 200 and withdrawn through the aperture308A, when the cassette 200 is installed in the autoinjector 300. Assoon as the shield remover 240 passes out through the aperture 308A, thetongues 245T of the expandable partial collar structure 245 expand orspread outwardly, thereby preventing the shield remover 240 and theneedle shield 266 attached thereto from being re-inserted into theaperture 308A of the cassette door 308. The proximal end wall of theautoinjector 300 may further comprise a target light 320. The targetlight 320 may be constructed and adapted to turn on when the shieldremover 240 is removed from the cassette 200 and withdrawn through theaperture 308A, thereby visually indicating that the shield remover 240has been removed. Once turned on, the target light aids the user invisualizing and selecting an injection site.

Referring still to FIG. 6E, the autoinjector 300 may further comprise acapacitance-based skin sensor 380 (shown with broken lines). The skinsensor 380 determines when the proximal end wall 318 of the autoinjector300 touches or contacts skin without the need to provide downwardpressure on the injection-site area. The skin sensor 380 may also beconstructed and adapted to inform the user through audible and visualindicators generated by the speaker and user interface, when skincontact is detected. In some embodiments, the skin sensor 380 maycomprise two pads or electrodes (not shown) imbedded in the proximal endwall 318 of the autoinjector 300. When an electrode is touched, itscapacitance signal increases. If the increase is sufficient asdetermined by the microprocessor (e.g. microprocessor 350 illustrated inFIG. 8), which is programmed with sensor decision logic, that electrodewill become activated. To determine whether skin contact has been made,the microprocessor reads the capacitance of the electrodes. Themicroprocessor then processes the capacitance information to determinewhen the electrodes are both making proper contact with the skin.

FIG. 7 is a state diagram illustrating the decision logic forcontrolling skin sensor 380 with the microprocessor 350 of theautoinjector 300, according to an embodiment of the present disclosure.The process starts at 400 which represents a reset of the autoinjector.The logic then flows to state 402 which represents the initialization ofthe skin sensor after the reset of the autoinjector. Once initialized,the logic flows to state 404 which represents a “no-touch” state wherenone or only one of electrodes of the sensor touch skin. If bothelectrodes touch skin for less than a certain threshold time period(e.g., one second), the logic flows to state 406 which represents a“touching” state. If one or neither one of the electrodes touches skin,the logic flows back to state 404. If, however, both electrodes touchskin for a period of time equal to the threshold time period, the logicflows to state 408 which represents a “touch OK” state. If one electrodeor no electrodes contact skin, the logic flows to a “releasing” state410. If both electrodes touch skin, the logic flows back to “touch OK”state 408. If one or no electrodes contact skin for more than thethreshold time period (e.g., more than one second), the logic flows backto “no touch” state 404.

FIG. 8 illustrates a sectional side view of the autoinjector apparatus100. comprising the autoinjector 300 and the cassette 200 installedtherein. The casing 302 of the autoinjector 300 may house a chassis 301for receiving the cassette 200 that contains the syringe 260, amotorized insertion drive 330, a motorized extrusion drive 340, amicroprocessor 350 (described earlier), a battery 360 for powering thedrives 330, 340 and the microprocessor 350, and the skin sensor 380(described earlier).

The microprocessor 350 may be programmed with certain instructions thatexecuted by the microprocessor 350 enable it to control and monitor thevarious operations and functions of the autoinjector 300. For example,but not limitation, the microprocessor may be programmed withinstructions for controlling the motorized insertion and extrusiondrives 330, 340 such that it controls and monitors each step of theinjection cycle and process flow, thereby automating needle insertion,drug extrusion, and needle retraction and ensuring accurate, consistent,and reliable operation of the autoinjector 300 and pharmaceuticalproduct administration. The microprocessor may also be programmed withinstructions for controlling the audible and visual feedbacks to theuser. An automated power-on self-test checks the operation of theautoinjector 300 and remaining battery charge.

FIG. 9 is a flow chart illustrating the decision logic for controllingthe various functions of the autoinjector 300 with the microprocessor350, according to an exemplary embodiment of the present disclosure. Themicroprocessor logic of the autoinjector commences in block 500 with theautoinjector is in an “off, (cassette) door closed” state. If the userpresses the eject button, the microprocessor may place the autoinjectorin a “device startup” state in block 502 unless the microprocessordetermines the following error conditions have occurred: 1) that theautoinjector is “out of life,” i.e., autoinjector usage has exceeded apredetermined time period (e.g., two (2) years), or has exceeded apredetermined number of injections (e.g., 130 injections); 2) anunrecoverable device error has occurred; 3) the autoinjector's batteryis dead; 4) a defective cassette has been inserted into theautoinjector; or 5) the autoinjector is below a predeterminedtemperature. If any of the error conditions 1-3 have occurred, visualand audio error messages or alerts corresponding to blocks 504, 506, and508 may be implemented by the microprocessor, e.g., the user interfacemay fast blink a “device failure” icon (FIG. 13) for a predeterminedtime period (e.g., 60 seconds), and the audio speaker may generate acertain sound that indicates a device error. If the error condition 4has occurred, visual and audio error messages or alerts corresponding toblock 510 may be implemented by the microprocessor, e.g., the userinterface may blink a “cassette failure” icon (FIG. 13) for apredetermined time period (e.g., 60 seconds) and the audio speaker maygenerate the device error sound. The microprocessor may then open thecassette door after a predetermined time period (e.g., two (2) seconds)and place the autoinjector into a “door open, sleep B” state in block546. If the cassette is removed and the cassette door is closed, themicroprocessor may place the autoinjector in the “off, door closed”state of block 500. If the error condition 5 has occurred, visual andaudio error messages or alerts corresponding to block 512 may beimplemented by the microprocessor, e.g., the user interface may blink a“low temp” icon (FIG. 13) for a predetermined time period (e.g., 60seconds) and the speaker may generate the device error sound. Themicroprocessor may then place the autoinjector back in the “off, doorclosed” state of block 500.

Referring still to FIG. 9, if no errors conditions are detected, themicroprocessor may place the autoinjector in the “device startup” statein block 502, where it may cause the LEDs of the user interface toremain off and no sound to be generated by the audio speaker. Themicroprocessor may then open the cassette door, which places theautoinjector into a “door open, sleep state A” in block 514. If acassette is inserted and the cassette door closed, the microprocessormay cause the autoinjector to enter a “device visibly wakes up” state inblock 516, where it turns on the backlight and generates sound with theaudio speaker that indicates that the autoinjector is awake. If a badcassette is detected by the microprocessor, it may generate visual andaudible error alerts in block 518, e.g., the user interface may blink a“cassette failure” icon (FIG. 13) for a predetermined time period (e.g.,60 seconds) and the audio speaker may generate the device error sound.The microprocessor may then open the cassette door after a predeterminedtime period (e.g., two (2) seconds) and place the autoinjector into the“door open, sleep B” state of block 546 so that the cassette can beremoved. If the cassette door is subsequently closed, the microprocessormay place the autoinjector into the “off, door close” state of block500. If the eject button is pressed, the microprocessor may place theautoinjector into the “door open, sleep A” state of block 514. Once theautoinjector is in the “device visibly wakes up” state of block 516,removal of the shield remover of the cassette may cause themicroprocessor to place the autoinjector in a “cap off” state of block522, wherein it turns on the target light and continues to keep thebacklight on. If, however, the shield remover is not removed after theautoinjector has entered the “device visibly wakes up” state of block516 within a predetermined time period (e.g., 60 seconds), themicroprocessor may place the autoinjector in a “cassette in, sleep”state in block 520, where it turns off the LEDs and turns off thespeaker (no sound). If the start or eject button is then pressed, themicroprocessor may place the autoinjector back into the “device visiblywakes up” state of block 516. If, however, the shield remover is removed(after entering the “cassette in, sleep” state of block 520), themicroprocessor may place the autoinjector in the “cap off” state ofblock 522, as previously described.

Referring still to FIG. 9, once the target light is turned on in the“cap off” state of block 522, touching the proximal end wall of theautoinjector to skin at the injection site so that the skin sensorsenses contact with skin, may cause the microprocessor to may place theautoinjector into a “ready to inject” state in block 526, where itcontinuously illuminates the start button in a first predetermined color(e.g., green), turns on all progress LEDs 550 of the user interface(FIG. 12), generates a sound with the speaker that indicates that theinjector is ready to start and injection cycle, turns off the targetlight, keeps on the backlight so that the user can view the progress ofthe injection in the syringe. If the skin sensor does not sense contactwith skin within a predetermined time period (e.g., 60 seconds) afterentering the “read to inject” state of block 526, the microprocessor mayplace the autoinjector in a “cap off sleep” state in block 524, where itturns off the progress LEDs 550 (FIG. 12) and the audio speaker. If thestart or eject button is subsequently pressed, the microprocessor mayplace the autoinjector into the “cap off” state in block 522, aspreviously described. If, however, the start or eject button issubsequently pressed and the skin sensor senses contact with skin, themicroprocessor may place the autoinjector in to the “ready to inject”state of block 526, as previously described. If the autoinjector is thenlifted off the skin, the microprocessor may place the autoinjector backin the “cap on” state of block 522.

Referring again to FIG. 9, with the autoinjector in the “ready toinject” state of block 526, pressing the start button causes themicroprocessor to place the autoinjector into an “injection start” statein block 528, where it changes the continuous illumination of startbutton to a second predetermined color (e.g., blue) and keeps thebacklight and the progress LED on. If the microprocessor detects thatthe injection needle is not pushed into the skin, it may retract theneedle and visually and audibly alert a needle jam in block 530, e.g.,the user interface may blink “cassette fail” icon (FIG. 13) for apredetermined time period (e.g., 60 seconds) and the speaker maygenerate the error sound. The microprocessor may then open the cassettedoor after a predetermined time period and place the autoinjector in the“door open, sleep B” state of block 546. If, however, the injectionneedle pushes into the skin, and after a predetermine time period haselapsed (e.g., 0.5 seconds), the microprocessor may place theautoinjector in an “injection progress” state in block 532, where thestart button may remain continuously illuminated in the secondpredetermined color and the backlight and the progress LED may remainon. If the plunger subsequently pushes a clogged cassette, themicroprocessor may retract the injection needle and visibly and audiblysignal in block 534 a plunger jam, i.e., the user interface may blink a“cassette fail” icon (FIG. 13) for a predetermined time period (e.g., 60seconds) and the speaker may generate the error sound. Themicroprocessor may then open the cassette door after a predeterminedtime period and place the autoinjector into the “door open, sleep B”state of block 546. If, instead, the autoinjector is lifted off the skinbeyond an acceptable limit for a predetermined time period (e.g., 1second), the microprocessor may retract the injection needle and visiblyand audibly signal in block 536 an “off skin too long” alert, e.g., theuser interface may blink a “cassette fail” icon (FIG. 13) for apredetermined time period (e.g., 60 seconds) and the speaker maygenerate the error sound.

Returning to block 532 of FIG. 9, as selected drug injection time periodelapses the progress LEDs 550 (FIG. 12) may be sequentially turned offby the microprocessor to indicate the progression of the injectioncycle. Once the injection cycle has completed, the microprocessor mayretract the injection needle thereby placing the autoinjector into a“needle retraction” state in block 538, where it continuouslyilluminates the start button in the second predetermined color,maintains the backlight in the on state and maintains only one of theprogress LEDs 550 (FIG. 12) in the on state. The microprocessor may thenpartially retract the plunger rod and fully retract the injection needlethereby placing the autoinjector in an “injection complete” state andindicate in block 540, where it may change the illumination color of thestart button back to the first predetermined color, turn off thebacklight and last progress LED 550 (FIG. 12), and generate a sound withthe audio speaker that indicates that the injection is complete. If theautoinjector is removed from the skin for a predetermine time period(e.g., 5 second) elapses, the microprocessor may place the autoinjectorin a “plunger retraction” state in block 542, and may terminate theillumination of the start button. The microprocessor may then retractthe plunger rod and automatically open the cassette door in block 544which places the autoinjector in the “door open, sleep B” state of block546. Removal of the spent cassette can now be made and the cassette doorclosed, which places the autoinjector in the “off, door closed” state ofblock 500. If the microprocessor detects a low battery in the “automaticdoor open” state of block 544, (which may indicate that a certain numberof injections remain, that a certain number of injections have beenmade, or that a certain number of days of usage has passed) themicroprocessor may cause the autoinjector to visibly and audibly signala “battery low” error alert by blinking the “low battery” icon (FIG. 13)with the user interface and generating the error sound with the audiospeaker.

Referring again to FIG. 8, the motorized insertion drive 330 performs aneedle insertion cycle and a needle retraction cycle. FIGS. 10A and 10Brespectively illustrate a top down perspective side view and a bottom upperspective side view of an embodiment of the motorized insertion drive330. The insertion drive 300 may comprise an insertion drive motor 331,a drive link or rack 332, and an insertion drive gear train 333including a plurality of gears 333 ₁, 333 ₂, 333 ₃, 333 ₄, fortransmitting the rotary motion of the insertion drive motor 331 to drivethe rack 332. The rack 332 may include a top surface 332T and a bottomsurface 332B. The top surface 332T of the rack 332 may includespaced-apart first and second protrusions, 332 ₁ and 332 ₂,respectively. The bottom surface 332B of the rack 332 may include rackteeth 334. The rack teeth 334 of the rack engage gear 333 ₄ of the geartrain 333. During a needle insertion cycle, the first protrusion 332 ₁of the rack 332 unlatches the inner sleeve pin 268 of the inner sleeve220 of the cassette 200 from the latch 218 of the outer cassette housing210 (FIG. 3B) and then engages and then pushes the inner sleeve pin 268to drive the inner sleeve 220 containing the syringe 260 forward withinthe outer housing of the cassette 200 from the home position to theneedle extended position where the injection needle 265 of the syringe260 extends out from the cassette 200 and is inserted into the skin atthe injection site. During a needle retraction cycle, the secondprotrusion 332 ₂ of the rack 332 engages and then pulls the inner sleevepin 268 to drive the inner sleeve 220 containing the syringe 260backward within the outer housing of the cassette 200 into the homeposition again, thereby withdrawing the injection needle 265 of thesyringe 260 from the skin at the injection site and retracting it backinto the cassette 200 (after drug extrusion) where the needle isshielded and locked within the cassette 200 for safe handling anddisposal. The needle insertion positioning and timing are monitored andcontrolled by the microprocessor 350 of the autoinjector. If an erroroccurs, the error will be indicated on the user interface 312 (FIG. 6A)along with audible alert from the speaker. The insertion drive 330enables the autoinjector apparatus 100 to deliver the pharmaceuticalproduct subcutaneously (SC) with a predetermined needle injection depth.This needle-depth parameter is accomplished when the insertion drive 330moves the inner sleeve 220/syringe 260 forward to a mechanical hard stopwithin the outer housing 210 of the cassette 200. The mechanical hardstop limits the travel of the syringe 260 in the direction of thepatient's skin, ensuring needle depth to the desired predeterminedspecification. Monitoring the movement of the motor 331 enablesdetection of incomplete needle insertion, which will trigger needleretraction and termination of the injection cycle, accompanied byaudible and visual alerts.

The motorized extrusion drive 340 illustrated in FIG. 8, performs thedrug extrusion cycle where the pharmaceutical product is emptied fromthe syringe 260. FIGS. 11A-11B are perspective side views illustratingan embodiment of the motorized extrusion drive 340. FIG. 11A illustratesan exploded perspective side view of an embodiment of a plungerrod/drive screw arrangement of the motorized extrusion drive 340. FIG.11B illustrates an assembled perspective side view of the plungerrod/drive screw arrangement illustrated in FIG. 11A. FIG. 11Cillustrates a perspective view of an embodiment of a gear train of themotorized insertion drive 330. The extrusion drive 340 may comprise anextrusion drive motor 341, a plunger rod 342, a lead screw 343, and anextrusion drive gear train 344. The plunger rod 342 is driven by theextrusion drive motor 341 through the lead screw 343 and the extrusiondrive gear train 344. As illustrated in FIGS. 11A and B, the plunger rod342 may include a pusher 342P and the lead screw 343 may include a nut345. The nut 345 mechanically couples the plunger rod 342 to the leadscrew 343. The nut 345 may include an internal screw thread 345T thatthreadedly engages an external screw thread 343T of the lead screw 343.The nut 35 may also include a holder 345H that fixedly holds the pusher342P of the plunger rod 342. As illustrated in FIG. 11C, the extrusiondrive gear train 344 may include a plurality of gears 3441, 3442, 3443,3444, 3445, 3446. The gears 3441 and 3446 of the extrusion drive geartrain 344 are coupled to the extrusion drive motor 341 and the leadscrew 343, respectively, thereby allowing the extrusion drive gear train344 to transmit the rotary motion of the insertion drive motor 331 todrive the lead screw 343. As the lead screw 343 rotates, the nut 345(which is threadedly engaged with the lead screw 343) moves forward orbackward (depending upon the lead screw's direction of rotation) alongthe lead screw 343, which in turn, drives the plunger rod 342 forwardand backward in the autoinjector 300. Forward movement of the plungerrod 342 causes an end face 342EF of the plunger rod 342 to enter thecassette 200 and subsequently the syringe barrel 261 of the syringe 260.The plunger rod 343 then engages the plunger-stopper 264 of the syringe260 and pushes it to the end of the syringe barrel 261 in order to expelthe predetermined dose of the pharmaceutical product from the syringe260 during a drug extrusion cycle. The position of the components ofextrusion drive 340, as well as time related to drug extrusion, may bemonitored by the microprocessor 350. If an error occurs, the error canbe indicated on the user interface 312 along with an audible alert. Themicroprocessor 350 may be capable of storing different factory-set drugdelivery profiles (stroke, speed, acceleration). A plurality of uniquedrug delivery profiles may be associated with specific cassetteconfigurations. The cassette identification arrangement on the outerhousing 210 of the cassette 200 enable the autoinjector 300 to identifythe proper drug delivery profile specific for the loaded pharmaceuticalproduct. Upon insertion and recognition of a valid cassette 200,available preset drug extrusion speed ranges may be automaticallyregistered by the autoinjector 300. Available speed ranges are dependentupon the syringe fill volume and pharmaceutical product characteristics,such as viscosity.

The user may select the desired drug extrusion speed (defined as thetime to empty the pharmaceutical product of the syringe 260) from aplurality of different options for a particular pharmaceutical productusing the speed selector switch 316. Upon initiation of the drugextrusion cycle, the stroke of the plunger rod 342 may be controlled andmonitored to ensure the plunger-stopper 264 reaches the end of thesyringe barrel 261, which ensures complete dose administration. If anerror occurs during the extrusion process (e.g., failure of the plungerrod to achieve a complete stroke), the autoinjector 300 may immediatelyterminate drug extrusion, retract the needle back into the cassette 200,and provide audible and visual alerts.

The injection cycles may be indicated by both audible and visualsignals. Lights on the autoinjector 300 may turn off in sequence fromtop to bottom during the injection cycle to indicate to the user theprogress of the injection. Upon completion of the injection cycle, theautoinjector 300 retracts the syringe needle back into the disposablecassette 200, and then opens the cassette door 308 automatically,allowing removal of the cassette 200 by the user. The opening of thecassette door 308 may also be an indicator to the user that theinjection cycle is complete.

In the event that an error occurs during the injection cycle, theautoinjector 300 may be equipped with various audible and visual signalsto alert the user (operator or patient) to the error and to promptappropriate actions.

The battery 360 illustrated in FIG. 8, may be a non-replaceable,non-rechargeable battery. The battery 360 should be capable of providingsufficient power for adequate shelf-life and service life to meet thedrug delivery requirements. A power-on self test is automaticallyperformed upon waking the autoinjector 300 to ensure sufficient batterypower is available for a successful injection cycle. The user interface312 of the autoinjector 300 may provide visual and audible alerts if aproblem occurs with the battery 360 before injection. The microprocessor350 may be programmed to disable the autoinjector 300 at the end of thedefined service life.

The syringe 260 of the cassette 200 may be prefilled with apharmaceutical product, such as an erythropoiesis stimulating agent(ESA), which may be in a liquid or a lyophilized form. An ESA can be anerythropoiesis stimulating protein. As used herein, “erythropoiesisstimulating protein” means any protein that directly or indirectlycauses activation of the erythropoietin receptor, for example, bybinding to and causing dimerization of the receptor. Erythropoiesisstimulating proteins comprise erythropoietin and variants, analogs, orderivatives thereof that bind to and activate erythropoietin receptor;antibodies that bind to erythropoietin receptor and activate thereceptor; or peptides that bind to and activate erythropoietin receptor.Erythropoiesis stimulating proteins comprise, but are not limited to,epoetin alfa, epoetin beta, epoetin delta, epoetin omega, epoetin iota,epoetin zeta, and analogs thereof, pegylated erythropoietin,carbamylated erythropoietin, mimetic peptides (comprisingEMP1/Hematide), and mimetic antibodies. Exemplary erythropoiesisstimulating proteins comprise erythropoietin, darbepoetin,erythropoietin agonist variants, and peptides or antibodies that bindand activate erythropoietin receptor.

The term erythropoiesis stimulating protein comprises without limitationEpogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetindelta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide™(peginesatide), MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon®(epoetin beta), Silapo™ (epoetin zeta), Binocrit® (epoetin alfa),epoetin alfa Hexal, Abseamed™ (epoetin alfa), Ratioepo™ (epoetin theta),Eporatio™ (epoetin theta), Biopoin™ (epoetin theta), epoetin alfa,epoetin beta, epoetin zeta, epoetin theta, and epoetin delta.

The term erythropoiesis stimulating protein further comprises themolecules or variants or analogs as disclosed in the following patentsor patent applications: U.S. Pat. Nos. 4,703,008; 5,441,868; 5,547,933;5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,830,851;5,856,298; 5,955,422; 5,986,047; 6,030,086; 6,310,078; 6,391,633;6,583,272; 6,586,398; 6,900,292; 6,750,369; 7,030,226; 7,084,245; and7,271,689; U.S. Publ. Nos. 2002/0155998; 2003/0077753; 2003/0082749;2003/0143202; 2003/0215444; 2004/0009902; 2004/0071694; 2004/0091961;2004/0143857; 2004/0157293; 2004/0175379; 2004/0175824; 2004/0229318;2004/0248815; 2004/0266690; 2005/0019914; 2005/0026834; 2005/0096461;2005/0107297; 2005/0107591; 2005/0124045; 2005/0124564; 2005/0137329;2005/0142642; 2005/0143292; 2005/0153879; 2005/0158822; 2005/0158832;2005/0170457; 2005/0181359; 2005/0181482; 2005/0192211; 2005/0202538;2005/0227289; 2005/0244409; 2006/0040858; 2006/0088906; and2006/0111279; and PCT Publ. Nos. WO 91/05867; WO 95/05465; WO 96/40772;WO 99/66054; WO 00/24893; WO 01/81405; WO 00/61637; WO 01/36489; WO02/014356; WO 02/19963; WO 02/20034; WO 02/49673; WO 02/085940; WO03/029291; WO 2003/055526; WO 2003/084477; WO 2003/094858; WO2004/002417; WO 2004/002424; WO 2004/009627; WO 2004/024761; WO2004/033651; WO 2004/035603; WO 2004/043382; WO 2004/101600; WO2004/101606; WO 2004/101611; WO 2004/106373; WO 2004/018667; WO2005/001025; WO 2005/001136; WO 2005/021579; WO 2005/025606; WO2005/032460; WO 2005/051327; WO 2005/063808; WO 2005/063809; WO2005/070451; WO 2005/081687; WO 2005/084711; WO 2005/103076; WO2005/100403; WO 2005/092369; WO 2006/50959; WO 2006/02646; WO2006/29094; and WO 2007/136752.

Alternatively, the syringe 260 of the cassette 200 may also be prefilledwith other products. Examples of other pharmaceutical products that maybe used may comprise, but are not limited to, therapeutics such as abiological (e.g., Enbrel® (etanercept, TNF-receptor/Fc fusion protein,TNF blocker), anti-TNF antibodies such as adalimumab, infliximab,certolizumab pegol, and golimumab; anti-IL-12 antibodies such asustekinumab, other Fc fusions such as CTL4A:Fc also known as abacept;Neulasta0 (pegylated filgastrim, pegylated G-CSF, pegylatedhu-met-G-CSF), Neupogen® (filgrastim, G-CSF, hu-met-G-CSF), Nplate®(romiplostim), Vectibix® (panitumumab), Sensipar® (cinacalcet), andXgeva® and Prolia® (each denosamab, AMG 162); as well as other smallmolecule drugs, a therapeutic antibodies, a polypeptides, proteins orother chemicals, such as an iron (e.g., ferumoxytol, iron dextrans,ferric glyconate, and iron sucrose). The therapeutic may be in liquidform, or reconstituted from lyophilized form.

Among particular illustrative proteins that can be used in the syringe260 of the cassette 200 are antibodies, peptibodies, pegylated proteins,polypeptides, and related proteins (comprising fusions, fragments,analogs, variants or derivatives thereof) for example, proteins thatspecifically bind to: OPGL; TL-4 receptor; interleukin 1-receptor 1(“IL1-R1”); angiopoietin-2 (Ang2); NGF; CD22; IGF-1; B-7 related protein1 (B7RP1); IL-15; IL-17 Receptor A: IFN gamma; TALL-1; parathyroidhormone (“PTH”); thrombopoietin receptor (“TPO-R”); hepatocyte growthfactor (“HGF”); TRAIL-R2; Activin A; TGF-beta; amyloid-beta; c-Kit;a4137: and IL-23 or one of its subunits; and other therapeutic proteins.

The syringe 260 of the cassette 200 may also be prefilled with OPGLspecific antibodies, peptibodies, and related proteins, and the like(also referred to as RANKL specific antibodies, peptibodies and thelike), comprising fully humanized and human OPGL specific antibodies,particularly fully humanized monoclonal antibodies, comprising but notlimited to the antibodies described in PCT Publ. No. WO 03/002713,including OPGL specific antibodies and antibody related proteins,particularly those having the sequences set forth therein, particularly,but not limited to, those denoted therein: 9H7; 18B2; 2D8; 2E11; 16E1;and 22B3, comprising the OPGL specific antibodies having either thelight chain of SEQ ID NO: 2 therein as set forth in FIG. 2 thereinand/or the heavy chain of SEQ ID NO:4 therein, as set forth in FIG. 4therein.

The syringe 260 of the cassette 200 may also be prefilled with myostatinbinding proteins, peptibodies, and related proteins, and the like,comprising myostatin specific peptibodies, particularly those describedin US Publ. No. 2004/0181033 and PCT Publ. No. WO 2004/058988,particularly in parts pertinent to myostatin specific peptibodies,comprising but not limited to peptibodies of the mTN8-19 family,comprising those of SEQ ID NOS: 305-351, comprising TN8-19-1 throughTN8-19-40, TN8-19 con1 and TN8-19 con2; peptibodies of the mL2 family ofSEQ ID NOS: 357-383 therein; the mL15 family of SEQ ID NOS: 384-409; themL17 family of SEQ ID NOS: 410-438 therein; the mL20 family of SEQ IDNOS: 439-446 therein;

the mL21 family of SEQ ID NOS: 447-452 therein; the mL24 family of SEQID NOS: 453-454 therein; and those of SEQ ID NOS: 615-631 therein.

The syringe 260 of the cassette 200 may also be prefilled with IL-4receptor specific antibodies, peptibodies, and related proteins, and thelike, particularly those that inhibit activities mediated by binding ofTL-4 and/or TL-1 3 to the receptor, comprising those described in PCTPubl. No. WO 2005/047331 or PCT Appl. No. PCT/US2004/03742 and in USPubl. No. 2005/112694, particularly in parts pertinent to IL-4 receptorspecific antibodies, particularly such antibodies as are describedtherein, particularly, and without limitation, those designated therein:L1H1; L1H2; L1H3; L1H4; L1H5; L1H6; L1H7; L1H8; L1H9; L1H10; L1H11;L2H1; L2H2; L2H3; L2H4; L2H5; L2H6; L2H7; L2H8; L2H9; L2H10; L2H11;L2H12; L2H13; L2H14; L3H1; L4H1; L5H1; L6H1.

The syringe 260 of the cassette 200 may also be prefilled with IL1-R1specific antibodies, peptibodies, and related proteins, and the like,comprising but not limited to those described in U.S. Publ. No.2004/097712A1, including in parts pertinent to IL1-R1 specific bindingproteins, monoclonal antibodies in particular, especially, withoutlimitation, those designated therein: 15CA, 26F5, 27F2, 24E12, and 10H7.

The syringe 260 of the cassette 200 also be prefilled with Ang2 specificantibodies, peptibodies, and related proteins, and the like, comprisingbut not limited to those described in PCT Publ. No. WO 03/057134 andU.S. Publ No. 2003/0229023, particularly in parts pertinent to Ang2specific antibodies and peptibodies and the like, especially those ofsequences described therein and comprising but not limited to: L1(N);L1(N) WT; L1(N) 1K WT; 2×L1(N); 2×L1(N) WT; Con4 (N), Con4 (N) 1K WT,2×Con4 (N) 1K; L1C; L1C 1K; 2×L1C; Con4C; Con4C 1K; 2×Con4C 1K; Con4-L1(N); Con4-L1C; TN-12-9 (N); C17 (N); TN8-8(N); TN8-14 (N); Con 1 (N),also comprising anti-Ang 2 antibodies and formulations such as thosedescribed in PCT Publ. No. WO 2003/030833 particularly Ab526; Ab528;Ab531; Ab533; Ab535; Ab536; Ab537; Ab540; Ab543; Ab544; Ab545; Ab546;A551; Ab553; Ab555; Ab558; Ab559; Ab565; AbF1AbFD; AbFE; AbFJ; AbFK;AbG1D4; AbGC1E8; AbH1C12; Ab1A1; Ab1F; Ab1K, Ab1P; and Ab1P, in theirvarious permutations as described therein.

The syringe 260 of the cassette 200 may also be prefilled with NGFspecific antibodies, peptibodies, and related proteins, and the likecomprising, in particular, but not limited to those described in USPubl. No. 2005/0074821 and U.S. Pat. No. 6,919,426, particularly as toNGF-specific antibodies and related proteins in this regard, comprisingin particular, but not limited to, the NGF-specific antibodies thereindesignated 4D4, 4G6, 6H9, 7H2, 14D10 and 14D11.

The syringe 260 of the cassette 200 may also be prefilled with CD22specific antibodies, peptibodies, and related proteins, and the like,such as those described in U.S. Pat. No. 5,789,554, particularly as toCD22 specific antibodies and related proteins, particularly human CD22specific antibodies, such as but not limited to humanized and fullyhuman antibodies, comprising but not limited to humanized and fullyhuman monoclonal antibodies, particularly comprising but not limited tohuman CD22 specific IgG antibodies, such as, for instance, a dimer of ahuman-mouse monoclonal hLL2 gamma-chain disulfide linked to ahuman-mouse monoclonal hLL2 kappa-chain, comprising, but limited to, forexample, the human CD22 specific fully humanized antibody inEpratuzumab, CAS registry number 501423-23-0;

The syringe 260 of the cassette 200 may also be prefilled with IGF-1receptor specific antibodies, peptibodies, and related proteins, and thelike, such as those described in PCT Publ. No. WO 06/069202,particularly as to TGF-1 receptor specific antibodies and relatedproteins, comprising but not limited to the IGF-1 specific antibodiestherein designated L1H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9,L10H10, L11H11, L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18,L19H19, L20H20, L21H21, L22H22, L23H23, L24H24, L25H25, L26H26, L27H27,L28H28, L29H29, L30H30, L31H31, L32H32, L33H33, L34H34, L35H35, L36H36,L37H37, L38H38, L39H39, L40H40, L41H41, L42H42, L43H43, L44H44, L45H45,L46H46, L47H47, L48H48, L49H49, L50H50, L51H51, L52H52, andIGF-1R-binding fragments and derivatives thereof.

Also among non-limiting examples of anti-IGF-1R antibodies for use inthe methods and compositions of the present invention are each and allof those described in: (i) US Publ. No. 2006/0040358 (published Feb. 23,2006), 2005/0008642 (published Jan. 13, 2005), 2004/0228859 (publishedNov. 18, 2004), comprising but not limited to, for instance, antibody 1A(DSMZ Deposit No. DSM ACC 2586), antibody 8 (DSMZ Deposit No. DSM ACC2589), antibody 23 (DSMZ Deposit No. DSM ACC 2588) and antibody 18 asdescribed therein; (ii) PCT Publ. No. WO 06/138729 (published Dec. 28,2006) and WO 05/016970 (published Feb. 24, 2005), and Lu et al., 2004, JBiol. Chem. 279:2856-65, comprising but not limited to antibodies 2F8,A12, and IMC-A12 as described therein; (iii) PCT Publ. No. WO 07/012614(published Feb. 1, 2007), WO 07/000328 (published Jan. 4, 2007), WO06/013472 (published Feb. 9, 2006), WO 05/058967 (published Jun. 30,2005), and WO 03/059951 (published Jul. 24, 2003); (iv) US Publ. No.2005/0084906 (published Apr. 21, 2005), comprising but not limited toantibody 7C10, chimaeric antibody C7C10, antibody h7C10, antibody 7H2M,chimaeric antibody *7C10, antibody GM 607, humanized antibody 7C10version 1, humanized antibody 7C10 version 2, humanized antibody 7C10version 3, and antibody 7H2HM, as described therein; (v) US Publ. Nos.2005/0249728 (published Nov. 10, 2005), 2005/0186203 (published Aug. 25,2005), 2004/0265307 (published Dec. 30, 2004), and 2003/0235582(published Dec. 25, 2003) and Maloney et al., 2003, Cancer Res.63:5073-83, comprising but not limited to antibody EM164, resurfacedEM164, humanized EM164, huEM164 v1.0, huEM164 v1.1, huEM164 v1.2, andhuEM164 v1.3 as described therein; (vi) U.S. Pat. No. 7,037,498 (issuedMay 2, 2006), US Publ. Nos. 2005/0244408 (published Nov. 30, 2005) and2004/0086503 (published May 6, 2004), and Cohen, et al., 2005, ClinicalCancer Res. 11:2063-73, e.g., antibody CP-751,871, comprising but notlimited to each of the antibodies produced by the hybridomas having theATCC accession numbers PTA-2792, PTA-2788, PTA-2790, PTA-2791, PTA-2789,PTA-2793, and antibodies 2.12.1, 2.13.2, 2.14.3, 3.1.1, 4.9.2, and4.17.3, as described therein; (vii) US Publ. Nos. 2005/0136063(published Jun. 23, 2005) and 2004/0018191 (published Jan. 29, 2004),comprising but not limited to antibody 19D12 and an antibody comprisinga heavy chain encoded by a polynucleotide in plasmid 15H12/19D12 HCA(y4), deposited at the ATCC under number PTA-5214, and a light chainencoded by a polynucleotide in plasmid 15H12/19D12 LCF (c), deposited atthe ATCC under number PTA-5220, as described therein; and (viii) USPubl. No. 2004/0202655 (published Oct. 14, 2004), comprising but notlimited to antibodies PINT-6A1, PINT-7A2, PINT-7A4, PINT-7A5, PINT-7A6,PINT-8A1, PINT-9A2, PINT-11A1, PINT-11A2, PINT-11A3, PINT-11A4,PINT-11A5, PINT-11A7, PINT-11A12, PINT-12A1, PINT-12A2, PINT-12A3,PINT-12A4, and PINT-12A5, as described therein; particularly as to theaforementioned antibodies, peptibodies, and related proteins and thelike that target IGF-1 receptors.

The syringe 260 of the cassette 200 may also be prefilled with B-7related protein 1 specific antibodies, peptibodies, related proteins andthe like (“B7RP-1,” also is referred to in the literature as B7H2,ICOSL, B7h, and CD275), particularly B7RP-specific fully humanmonoclonal IgG2 antibodies, particularly fully human IgG2 monoclonalantibody that binds an epitope in the first immunoglobulin-like domainof B7RP-1, especially those that inhibit the interaction of B7RP-1 withits natural receptor, TCOS, on activated T cells in particular,especially, in all of the foregoing regards, those disclosed in U.S.Publ. No. 2008/0166352 and PCT Publ. No. WO 07/011941, particularly asto such antibodies and related proteins, comprising but not limited toantibodies designated therein as follow: 16H (having light chainvariable and heavy chain variable sequences SEQ ID NO:1 and SEQ ID NO:7respectively therein); 5D (having light chain variable and heavy chainvariable sequences SEQ ID NO:2 and SEQ ID NO:9 respectively therein); 2H(having light chain variable and heavy chain variable sequences SEQ IDNO:3 and SEQ ID NO:10 respectively therein); 43H (having light chainvariable and heavy chain variable sequences SEQ ID NO:6 and SEQ ID NO:14respectively therein); 41H (having light chain variable and heavy chainvariable sequences SEQ ID NO:5 and SEQ ID NO:13 respectively therein);and 15H (having light chain variable and heavy chain variable sequencesSEQ ID NO:4 and SEQ ID NO:12 respectively therein).

The syringe 260 of the cassette 200 may also be prefilled with IL-15specific antibodies, peptibodies, and related proteins, and the like,such as, in particular, humanized monoclonal antibodies, particularlyantibodies such as those disclosed in U.S. Publ. Nos. 2003/0138421;2003/023586; and 2004/0071702; and U.S. Pat. No. 7,153,507, particularlyas to IL-15 specific antibodies and related proteins, comprisingpeptibodies, comprising particularly, for instance, but not limited to,HuMax IL-15 antibodies and related proteins, such as, for instance,146B7.

The syringe 260 of the cassette 200 may also be prefilled withpharmaceutical compositions comprising antagonistic human monoclonalantibodies against human IL-17 Receptor A. The characterization,cloning, and preparation of IL-17 Receptor A are described in U.S. Pat.No. 6,072,033, issued Jun. 6, 2000. The amino acid sequence of the humanIL-17RA is shown in SEQ ID NO:10 of U.S. Pat. No. 6,072,033 (GenBankaccession number NM 014339). Such antibodies may comprise thosedisclosed in WO 2008/054603, or the antibodies claimed in U.S. Pat. No.7,767,206, issued Aug. 3, 2010, and in U.S. Ser. No. 11/906,094.

The syringe 260 of the cassette 200 may also be prefilled with IFN gammaspecific antibodies, peptibodies, and related proteins and the like,especially human IFN gamma specific antibodies, particularly fully humananti-IFN gamma antibodies, such as, for instance, those described in USPubl. No. 2005/0004353, particularly as to IFN gamma specificantibodies, particularly, for example, the antibodies therein designated1118; 1118*; 1119; 1121; and 1121*. The entire sequences of the heavyand light chains of each of these antibodies, as well as the sequencesof their heavy and light chain variable regions and complementaritydetermining regions, as disclosed in the foregoing US Publication and inThakur et al., Mol. Immunol. 36:1107-1115 (1999). Specific antibodiescomprise those having the heavy chain of SEQ ID NO: 17 and the lightchain of SEQ ID NO:18; those having the heavy chain variable region ofSEQ ID NO:6 and the light chain variable region of SEQ ID NO:8; thosehaving the heavy chain of SEQ ID NO:19 and the light chain of SEQ IDNO:20; those having the heavy chain variable region of SEQ ID NO:10 andthe light chain variable region of SEQ ID NO:12; those having the heavychain of SEQ ID NO:32 and the light chain of SEQ ID NO:20; those havingthe heavy chain variable region of SEQ ID NO:30 and the light chainvariable region of SEQ ID NO:12; those having the heavy chain sequenceof SEQ ID NO:21 and the light chain sequence of SEQ ID NO:22; thosehaving the heavy chain variable region of SEQ ID NO:14 and the lightchain variable region of SEQ ID NO:16; those having the heavy chain ofSEQ ID NO:21 and the light chain of SEQ ID NO:33; and those having theheavy chain variable region of SEQ ID NO:14 and the light chain variableregion of SEQ ID NO:31, as disclosed in the foregoing US Publication. Aspecific antibody contemplated is antibody 1119 as disclosed inforegoing US Publication and having a complete heavy chain of SEQ IDNO:17 as disclosed therein and having a complete light chain of SEQ IDNO:18 as disclosed therein.

The syringe 260 of the cassette 200 may also be prefilled with TALL-1specific antibodies, peptibodies, and related proteins, and the like,and other TALL specific binding proteins, such as those described inU.S. Publ. Nos. 2003/0195156 and 2006/0135431, particularly as to TALL-1binding proteins, particularly the molecules of Tables 4 and 5B therein.

The syringe 260 of the cassette 200 may also be prefilled with PTHspecific antibodies, peptibodies, and related proteins, and the like,such as those described in U.S. Pat. No. 6,756,480, particularly inparts pertinent to proteins that bind PTH.

The syringe 260 of the cassette 200 may also be prefilled with TPO-Rspecific antibodies, peptibodies, and related proteins, and the like,such as those described in U.S. Pat. No. 6,835,809, particularly inparts pertinent to proteins that bind TPO-R.

The syringe 260 of the cassette 200 may also be prefilled with HGFspecific antibodies, peptibodies, and related proteins, and the like,comprising those that target the HGF/SF:cMet axis (HGF/SF:c-Met), suchas the fully human monoclonal antibodies that neutralize hepatocytegrowth factor/scatter (HGF/SF) described in US Publ. No. 2005/0118643and PCT Publ. No. WO 2005/017107, huL2G7 described in U.S. Pat. No.7,220,410 and OA-5d5 described in U.S. Pat. Nos. 5,686,292 and 6,468,529and in PCT Publ. No. WO 96/38557, particularly in parts pertinent toproteins that bind HGF.

The syringe 260 of the cassette 200 may also be prefilled with TRAIL-R2specific antibodies, peptibodies, related proteins and the like, such asthose described in U.S. Pat. No. 7,521,048, particularly in partspertinent to proteins that bind TRAIL-R2.

The syringe 260 of the cassette 200 may also be prefilled with Activin Aspecific antibodies, peptibodies, related proteins, and the like,comprising but not limited to those described in US Publ. No.2009/0234106, particularly in parts pertinent to proteins that bindActivin A.

The syringe 260 of the cassette 200 may also be prefilled with TGF-betaspecific antibodies, peptibodies, related proteins, and the like,comprising but not limited to those described in U.S. Pat. No. 6,803,453and US Publ. No. 2007/0110747, particularly in parts pertinent toproteins that bind TGF-beta.

The syringe 260 of the cassette 200 may also be prefilled withamyloid-beta protein specific antibodies, peptibodies, related proteins,and the like, comprising but not limited to those described in PCT Publ.No. WO 2006/081171, particularly in parts pertinent to proteins thatbind amyloid-beta proteins. One antibody contemplated is an antibodyhaving a heavy chain variable region comprising SEQ ID NO: 8 and a lightchain variable region having SEQ ID NO: 6 as disclosed in theInternational Publication.

The syringe 260 of the cassette 200 may also be prefilled with c-Kitspecific antibodies, peptibodies, related proteins, and the like,comprising but not limited to those described in Publ. No. 2007/0253951,particularly in parts pertinent to proteins that bind c-Kit and/or otherstem cell factor receptors.

The syringe 260 of the cassette 200 may also be prefilled with OX4OLspecific antibodies, peptibodies, related proteins, and the like,comprising but not limited to those described in U.S. application Ser.No. 11/068,289, particularly in parts pertinent to proteins that bindOX4OL and/or other ligands of the OX040 receptor.

The syringe 260 of the cassette 200 may also be prefilled with otherexemplary proteins comprising but are not limited to Activase®(Alteplase, tPA); Aranesp® (Darbepoetin alfa), Epogen® (Epoetin alfa, orerythropoietin); Avonex® (Interferon beta-1a); Bexxar® (Tositumomab,anti-CD22 monoclonal antibody); Betaseron® (Interferon-beta); Campath®(Alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (Epoetin delta);Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2chemokine receptor mAb); Enbrel® (etanercept, TNF-receptor/Fc fusionprotein, TNF blocker); Eprex® (Epoetin alfa); Erbitux® (Cetuximab,anti-EGFR/HER1/c-ErbB-1); Genotropin® (Somatropin, Human GrowthHormone); Herceptin® (Trastuzumab, anti-HER2/neu (erbB2) receptor mAb);Humatrope® (Somatropin, Human Growth Hormone); Humira® (Adalimumab);Insulin in Solution; Infergen® (Interferon Alfacon-1); Natrecor®(nesiritide; recombinant human B-type natriuretic peptide (hBNP);Kineret® (Anakinra), Leukinc® (Sargamostim, rhuGM-CSF); LymphoCide®(Epratuzumab, anti-CD22 mAb); Lymphostat B® (Belimumab, anti-BlyS mAb);Metalyse® (Tenecteplase, t-PA analog); Mircera® (methoxy polyethyleneglycol-epoetin beta); Mylotarg® (Gemtuzumab ozogamicin); Raptiva®(efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™(Eculizumab); Pexelizumab (Anti-05 Complement); MEDI-524 (Numax®);Lucentis® (Ranibizumab); 17-1A (Edrecolomab, Panorex®); Trabio®(lerdelimumab); TheraCim hR3 (Nimotuzumab); Omnitarg (Pertuzumab, 2C4);Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); Cantuzumabmertansine (huC242-DM1); NeoRecormon® (Epoetin beta); Neumega®(Oprelvekin, Human Interleukin-11); Neulasta® (Pegylated filgastrim,pegylated G-CSF, pegylated hu-Met-G-CSF); Neupogen® (Filgrastim, G-CSF,hu-MetG-CSF); Orthoclone OKT3® (Muromonab-CD3, anti-CD3 monoclonalantibody), Procrit® (Epoetin alfa); Remicade® (Infliximab, anti-TNFamonoclonal antibody), Reopro® (Abciximab, anti-GP 1Ib/Ilia receptormonoclonal antibody), Actemra® (anti-IL6 Receptor mAb), Avastin®(Bevacizumab), HuMax-CD4 (zanolimumab), Rituxan® (Rituximab, anti-CD20mAb); Tarceva® (Erlotinib); Roferon-A®-(Interferon alfa-2a); Simulect®(Basiliximab); Prexige® (lumiracoxib); Synagis® (Palivizumab); 146B7-CHO(anti-IL15 antibody, see U.S. Pat. No. 7,153,507), Tysabri®(Natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B.anthracis Protective Antigen mAb); ABthrax™; Vectibix® (Panitumumab);Xolair® (Omalizumab), ETI211 (anti-MRSA mAb), IL-1 Trap (the Fc portionof human IgG1 and the extracellular domains of both IL-1 receptorcomponents (the Type I receptor and receptor accessory protein)), VEGFTrap (Ig domains of VEGFR1 fused to IgG1 Fc), Zenapax® (Daclizumab);Zenapax® (Daclizumab, anti-IL-2Ra mAb), Zevalin® (Ibritumomab tiuxetan),Zetia (ezetimibe), Atacicept (TACT-Ig), anti-CD80 monoclonal antibody(mAb) (galiximab), anti-CD23 mAb (lumiliximab). BR2-Fc (huBR3/huFcfusion protein, soluble BAFF antagonist); CNTO 148 (Golimumab, anti-TNFαmAb); HGS-ETR1 (Mapatumumab; human anti-TRATL Receptor-1 mAb);HuMax-CD20 (Ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab);M200 (Volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab,anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-C. difficileToxin A and Toxin B C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC);anti-CD3 mAb (N1-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333(anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-CriptomAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019);anti-CTLA4 mAb; anti-eotaxin1 mAb (CAT-213); anti-FGF8 mAb;anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb(MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMaxHepC); anti-IFNα mAb (MEDI-545, MDX-1103); anti-IGF1R mAb; anti-IGF-1RmAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12/IL23 mAb (CNTO1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IP10Ulcerative Colitis mAb (MDX-1100); anti-LLY antibody; BMS-66513;anti-Mannose Receptor/hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRαantibody (IMC-3G3); anti-TGFB mAb (GC-1008); anti-TRAIL Receptor-2 humanmAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR/Flt-1 mAb; anti-ZP3 mAb(HuMax-ZP3); NVS Antibody #1; and NVS Antibody #2.

The syringe 260 of the cassette 200 may also be prefilled withantibodies comprising, but not limited to, those that recognize any oneor a combination of proteins comprising, but not limited to, theabove-mentioned proteins and/or the following antigens: CD2, CD3, CD4,CD8, CD11a, CD14, CD18, CD20, CD22, CD23, CD25, CD33, CD40, CD44, CD52,CD80 (B7.1), CD86 (B7.2), CD147, TL-1α, IL-1β, TL-2, IL-3, TL-7, TL-4,TL-5, TL-8, TL-10, TL-2 receptor, TL-4 receptor, IL-6 receptor, IL-13receptor, IL-18 receptor subunits, FGL2, PDGF-β and analogs thereof (seeU.S. Pat. Nos. 5,272,064 and 5,149,792), VEGF, TGF, TGF-β2, TGF-β1, EGFreceptor (see U.S. Pat. No. 6,235,883) VEGF receptor, hepatocyte growthfactor, osteoprotegerin ligand, interferon gamma, B lymphocytestimulator (BlyS, also known as BAFF, THANK, TALL-1, and zTNF4; see Doand Chen-Kiang (2002), Cytokine Growth Factor Rev. 13(1): 19-25), C5complement, TgE, tumor antigen CA125, tumor antigen MUC1, PEM antigen,LCG (which is a gene product that is expressed in association with lungcancer), HER-2, a tumor-associated glycoprotein TAG-72, the SK-1antigen, tumor-associated epitopes that are present in elevated levelsin the sera of patients with colon and/or pancreatic cancer,cancer-associated epitopes or proteins expressed on breast, colon,squamous cell, prostate, pancreatic, lung, and/or kidney cancer cellsand/or on melanoma, glioma, or neuroblastoma cells, the necrotic core ofa tumor, integrin alpha 4 beta 7, the integrin VLA-4, B2 integrins,TRAIL receptors 1, 2, 3, and 4, RANK, RANK ligand, TNF-α, the adhesionmolecule VAP-1, epithelial cell adhesion molecule (EpCAM), intercellularadhesion molecule-3 (ICAM-3), leukointegrin adhesin, the plateletglycoprotein gp TIb/TITa, cardiac myosin heavy chain, parathyroidhormone, rNAPc2 (which is an inhibitor of factor VIIa-tissue factor),MHC I, carcinoembryonic antigen (CEA), alpha-fetoprotein (AFP), tumornecrosis factor (TNF), CTLA-4 (which is a cytotoxic Tlymphocyte-associated antigen), Fc-γ-1 receptor, HLA-DR 10 beta, HLA-DRantigen, L-selectin, Respiratory Syncitial Virus, human immunodeficiencyvirus (HIV), hepatitis B virus (HBV), Streptococcus mutans, andStaphlycoccus aureus.

Additional examples of known antibodies that may be contained in thesyringe 260 of the cassette 200 can comprise but are not limited toadalimumab, bevacizumab, infliximab, abciximab, alemtuzumab,bapineuzumab, basiliximab, belimumab, briakinumab, canakinumab,certolizumab pegol, cetuximab, conatumumab, denosumab, eculizumab,gemtuzumab ozogamicin, golimumab, ibritumomab tiuxetan, labetuzumab,mapatumumab, matuzumab, mepolizumab, motavizumab, muromonab-CD3,natalizumab, nimotuzumab, ofatumumab, omalizumab, oregovomab,palivizumab, panitumumab, pemtumomab, pertuzumab, ranibizumab,rituximab, rovelizumab, tocilizumab, tositumomab, trastuzumab,ustekinumab, zalutumumab, and zanolimumab.

Although the autoinjector apparatus has been described in terms ofexemplary embodiments, it is not limited thereto. Rather, the appendedclaims should be construed broadly, to comprise other variants andembodiments of the autoinjector apparatus, which may be made by thoseskilled in the art without departing from the scope and range ofequivalents of the apparatus and its elements.

1. A single-use cassette for use with an autoinjector, the cassettecomprising: a housing; an inner sleeve disposed in the housing andmovable between first and second positions, a syringe disposed in theinner sleeve; and a lock cap for securing the syringe in the innersleeve, the lock cap including an elastomeric bumper, the lock capaffixed to a distal end of the inner sleeve with the elastomeric bumpercontacting a distal end of the syringe, wherein the distal end of theinner sleeve comprises at least one receptacle and the lock capcomprises at least one arm member for inserting into the receptacle.2-3. (canceled)
 4. The cassette of claim 1, wherein the at least one armmember of the lock cap comprises a barb arrangement for gripping aninner surface of the receptacle of the inner sleeve.
 5. (canceled) 6.The cassette of claim 1, wherein the cassette further comprises a shieldremover extending through an opening in a proximal end of the housingfor removing a needle shield from the syringe, wherein the shieldremover comprises a spring-biased tab, the tab disposed within anaperture defined in a wall of the housing.
 7. (canceled)
 8. The cassetteof claim 6, wherein the shield remover comprises an elongated bodyhaving a proximal end and a distal end, the distal end comprising atleast one flexible tongue that expands outwardly when the shield removeris removed from the cassette to prevent the shield remover from beingreinserted into the cassette.
 9. (canceled)
 10. The cassette of claim 1,further comprising a therapeutic product in the syringe.
 11. Thecassette of claim 10, wherein the therapeutic product is Epogen®,Aranesp®, Enbrel® Neulasta®, Neupogen®, Nplate®, Vectibix®, Sensipar®,Xgeva®, Prolia®, an antibody to IL-17 Receptor A, antagonist ofangiopoietin-2, a TNF blocker or inhibitor, etanercept, adalimumab,certolizumab, golimumab or infliximab. 12-16. (canceled)
 17. Thecassette of claim 1, further comprising a cassette identificationarrangement on a surface of the housing to enable the auto injector toidentify the cassette.
 18. The cassette of claim 14, wherein thecassette identification arrangement comprises at least one projection.19. An apparatus for injection of a therapeutic product, the apparatuscomprising: an auto injector; and a single-use cassette for use with theinjector, the cassette comprising: a housing; an inner sleeve disposedin the housing and movable between first and second positions; a syringedisposed in the inner sleeve; and a lock cap for securing the syringe inthe inner sleeve, the lock cap including an elastomeric bumper, the lockcap affixed to a distal end of the inner sleeve with the elastomericbumper contacting a distal end of the syringe, wherein the distal end ofthe inner sleeve comprises at least one receptacle and the lock capcomprises at least one arm member inserted into the receptacle. 20-21.(canceled)
 22. The apparatus of claim 19, wherein the at least one armmember of the lock cap comprises a barb arrangement for gripping aninner surface of the receptacle of the inner sleeve.
 23. The apparatusof claim 19, wherein the cassette further comprises a shield removerextending through an opening in a proximal end of the housing forremoving a needle shield from the syringe, wherein the shield removercomprises a spring-biased tab, the tab disposed within an aperturedefined in a wall of the housing to prevent removal of the shieldremover from the cassette.
 24. (canceled)
 25. The apparatus of claim 23,wherein the autoinjector comprises a pin for pushing the tab out of theaperture defined in the wall of the housing when the cassette is placedin the injector to thereby allow the shield remover to be removed fromthe cassette.
 26. The apparatus of claim 23, wherein the shield removercomprises an elongated body having a proximal end and a distal end, thedistal end comprising at least one flexible tongue that expandsoutwardly when the shield remover is removed from the cassette toprevent the shield remover from being reinserted into the cassette. 27.The apparatus of claim 19, further comprising a therapeutic product inthe syringe.
 28. The apparatus of claim 27, wherein the therapeuticproduct is Epogen®, Aranesp®, Enbrel® Neulasta®, Neupogen®, Nplate®,Vectibix®, Sensipar®, Xgeva®, Prolia®, an antibody to IL-17 Receptor A,an antagonist to angiopoietin-2, a TNF blocker or inhibitor, etanercept,adalimumab, certolizumab, golimumab, or infliximab. 29-33. (canceled)34. The apparatus of claim 19, further comprising a cassetteidentification arrangement on a surface of the housing to enable theauto injector to identify the cassette.
 35. The apparatus of claim 34,wherein the cassette identification arrangement comprises at least oneprojection.
 36. The apparatus of claim 34, wherein the autoinjectorcomprises a detector for reading the cassette identification arrangementto identify the cassette. 37-38. (canceled)
 39. The cassette of claim 1,wherein the distal end of the inner sleeve comprises at least tworeceptacles and the lock cap comprises at least two arm members forinserting into the receptacles.
 40. The apparatus of claim 19, whereinthe distal end of the inner sleeve comprises at least two receptaclesand the lock cap comprises at least two arm members inserted into thereceptacles.